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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019272
Receipt No. R000022202
Scientific Title Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Date of disclosure of the study information 2015/10/08
Last modified on 2015/10/08

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Basic information
Public title Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Acronym Efficacy of Mirabegron using Pressure Flow Study
Scientific Title Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Scientific Title:Acronym Efficacy of Mirabegron using Pressure Flow Study
Region
Japan

Condition
Condition overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of Mirabegron for treatment OAB using Urodynamic Study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes the change of storage and voiding function before and after administration
Key secondary outcomes the change of subjective symptom (IPSS, OABSS) before and after administration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Mirabegron 50mg/day for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Inclusion criteria were as follows: total OAB symptom scores (OABSS) of 3; urgency episodes 1 per week; post-menopausal women; and age 50 years.
Key exclusion criteria Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents; had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; or had severe cardiac disease, renal dysfunction (serum-creatinine;2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code
Address 65 tsurumai, Showa-ku, Nagoya
TEL +81-52-744-2985
Email yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code
Address 65 tsurumai, Showa-ku, Nagoya
TEL +81-52-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Department of Urology
Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院泌尿器科

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 60 patients with a mean age of 72.3 years (50-86 years) were included in the analysis. The subjective symptom parameter (i.e., the mean OABSS score) decreased significantly from 9.4 to 6.2 points (p < 0.001). In objective symptom parameters, both FDV and MCC significantly improved after treatment, and DO disappeared in 14 of 35 (40.0%) patients compared to that at baseline (p < 0.01). The voiding function parameters (i.e., mean Qmax, PdetQmax, and PVR) did not significantly change, demonstrating that mirabegron does not inhibit voiding function.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 15 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 10 Month 30 Day
Date analysis concluded
2014 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2015 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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